check_circleStudy Completed

Breast Cancer, Diagnostic Imaging

Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast MRI

Trial purpose

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
    - If female, a digital XRM is required if any of the following criteria is met:
    a. patient is younger than 50 years;
    b. patient has heterogeneously or extremely dense breasts;
    c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
    - If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
    - Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
  • - Is a female patient who is pregnant or lactating
    - Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
    - Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
    - Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
    - Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).
    - Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
    - Has received hormone replacement therapy within 4 weeks prior to study drug administration.
    - Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
    - Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM

Trial summary

Enrollment Goal
446
Trial Dates
February 2010 - January 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Lübeck, 23538, Germany
Completed
Magdeburg, 39120, Germany
Withdrawn
Hannover, 30625, Germany
Completed
Newport Beach, 92658-6100, United States
Terminated
Hospital Italiano Buenos AiresBuenos Aires, C1181ACH, Argentina
Terminated
Investigaciones MédicasBuenos Aires, C1082A, Argentina
Completed
Seoul, 150-713, Korea, Republic Of
Completed
Seoul, 138-736, Korea, Republic Of
Completed
Tübingen, 72076, Germany
Completed
Essen, 45257, Germany
Completed
Essen, 45147, Germany
Completed
Marburg, 35033, Germany
Completed
Potsdam, 14467, Germany
Completed
Dortmund, 44263, Germany
Completed
Bielefeld, Germany
Withdrawn
Boston, 02118, United States
Completed
Los Angeles, 90033, United States
Completed
La Jolla, 92093, United States
Completed
San Antonio, 78229, United States
Completed
Springfield II, 62781, United States
Terminated
Centro de Diagnóstico Dr. Enrique RossiBuenos Aires, C1425BEE, Argentina
Completed
Seoul, 135-710, Korea, Republic Of
Completed
Milano, 20097, Italy
Completed
Napoli, 80131, Italy
Withdrawn
Udine, 33100, Italy
Completed
Milano, 20141, Italy
Completed
Milano, 20132, Italy
Completed
Bogotá, Colombia
Completed
MEDELLIN, Colombia
Withdrawn
Barranquilla, Colombia
Terminated
Hospital Israelita Albert EinsteinSão Paulo, 05651-901, Brazil
Terminated
Clinica de Diagnostico por ImagemRio de Janeiro, 22649, Brazil
Terminated
Hospital Clínicas FMUSPSao Paulo, Brazil
Completed
Gyeonggi-do, 425-707, Korea, Republic Of
Withdrawn
Chur, 7000, Switzerland
Withdrawn
Bern, 3010, Switzerland
Completed
Baden, 5404, Switzerland
Completed
Tampere, 33521, Finland
Completed
Washington, 20007-2197, United States
Completed
DocratesHelsinki, 00180, Finland

Primary Outcome

  • Sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per reader
    For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM)
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • Difference for sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per reader
    For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants.
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • Breast level specificity of CMRM for non-malignant breasts by reader
    A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the point estimates were calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Breast level specificity of CMRM based on malignant breasts
    A malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference of participants whose index cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
    Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study.
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference of participants whose additional cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
    Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study.
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1